Take those medical journal pharmaceutical ads with grain of salt
Most pharmaceutical ads in biomedical journals may not be up to snuff as far as Food and Drug Administration guidelines are concerned, a study finds.
Researchers examined 192 pharmaceutical ads for 82 individual products in 12 journals from November 2008 using criteria from the FDA’s Prescription Drug Advertising Guidelines (excluded were ads for devices, over the counter medications and disease awareness). They also assessed ad content that related to safe prescribing. At least two people reviewed each ad.
Only about 18% of the ads complied with all 20 FDA guidelines and about 58% didn’t calculate serious risks of the drugs, including death.
About 49% of the ads may not have adhered to at least one FDA-ordered item and about 33% might not have complied because of incomplete information. About 48% didn’t have references that could be confirmed and almost 29% couldn’t adequately quantify effectiveness.
“The limited resources of the FDA’s Division of Drug Marketing and Advertising are a major barrier to successful regulation of the pharmaceutical industry’s multi-billion dollar marketing budget,” said lead author Dr. Deborah Korenstein of Mount Sinai School of Medicine in a news release. “We are hopeful that an update in FDA regulations, with increased emphasis on the transparent presentation of basic safety and efficacy information, might improve the quality of information provided in physician-directed pharmaceutical advertisements.”
The study was published online Wednesday in the journal PLoS One.